Shared analyst passwords detected during FDA inspection – 483 observation breakdown
During the FDA inspection, several symptoms indicated a potential breach in data integrity at the facility:Click to read the full article.
Deviation Case Studies
Manual result transcription without verification during FDA inspection – 483 observation breakdown
The FDA inspection revealed several key symptoms indicative of procedural failures. These symptoms suggested a lack of adherence to regulatory compliance and data integrity standards:Click to read the full article.
Backdated laboratory records during FDA inspection – remediation failure analysis
The first indication that a company might face issues with backdated laboratory records comes from various symptoms exhibiting themselves on the manufacturing floor or within the laboratory. These signals may…
Shared analyst passwords detected during system validation – remediation failure analysis
The first indicator of the data integrity breach emerged during a routine audit of user accounts in the laboratory information management system (LIMS). Anomalies were observed when multiple analysts were…
Audit trail deletion identified during internal audit – 483 observation breakdown
Symptoms of the audit trail deletion became evident during the routine internal audit when it was detected that some batch records were missing data entries in their audit trails. Specific…
Audit trail deletion identified during data review – remediation failure analysis
The issue emerged during a scheduled internal data review, wherein discrepancies were noted between recorded batch production data and the electronic batch record (EBR). It was found that audit trails…
Expired material issued to production during distribution – CAPA failure explained
The identification of the use of expired materials often begins with observable symptoms on the production floor. In this case, the following signals indicated a potential deviation:Click to read the…
Temperature excursion not assessed during material storage – CAPA failure explained
In this scenario, several symptoms indicated that a temperature excursion had potentially occurred:Click to read the full article.
Excursion trend ignored during inspection – product quality impact case study
The initial signals of the excursion trend emerged subtly over weeks, manifesting as minor fluctuations in temperature and humidity readings in the warehouse where critical raw materials were stored. Although…
Excursion trend ignored during material storage – product quality impact case study
The incident began with multiple reports from the Quality Control (QC) laboratory where analysis of API batches revealed impurities and a reduced potency compared to historical data. Specifically, the laboratory…
Cold chain monitoring failure during inspection – product quality impact case study
The failure of cold chain monitoring often manifests through various symptoms, which might not be immediately apparent. During a routine inspection, the following signals were identified:Click to read the full…
FEFO not followed during distribution – product quality impact case study
The initial signs of the failure to follow FEFO practices became evident during routine checks in the warehouse. Quality Control (QC) staff noted discrepancies in product expiration dates and inventory…